Electrical Impedance Tomography for Assessment of Pulmonary Hypertension

February 27, 2026 updated by: University of Sao Paulo General Hospital

Assessment of Pulmonary Artery Pressure and Hemodynamic Measurements by Electrical Impedance Tomography and Right Heart Catheterization

Pulmonary hypertension is a serious and progressive disease that is difficult to treat and diagnose, mainly because its symptoms are nonspecific and often delay recognition. Early diagnosis is a major challenge. Although several tests may suggest the disease, the definitive diagnosis still requires right heart catheterization, an invasive procedure that directly measures pulmonary hemodynamics such as pulmonary artery pressure, cardiac output, and vascular resistance.

Electrical impedance tomography (EIT) is a non-invasive, radiation-free bedside monitoring method that can evaluate ventilation and pulmonary perfusion. The number of studies investigating perfusion with EIT has been increasing, since the possibility of having a safe, radiation-free, and repeatable method available at the bedside is of great clinical interest in different fields of medicine.

Our hypothesis is that EIT provides information that correlates with the findings of right heart catheterization in patients with suspected pulmonary arterial hypertension (PAH). EIT may serve as a useful screening tool prior to catheterization and may also help in risk stratification of patients with pulmonary hypertension

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

This single-center, prospective diagnostic study is designed to investigate whether EIT-derived measures correlate with invasive hemodynamic parameters obtained by RHC. Adult patients referred for RHC due to suspected PAH or for disease staging will undergo standard catheterization, followed by short-term EIT monitoring. Some patients will additionally receive a hypertonic saline injection during a respiratory pause to enhance the perfusion signal. All EIT data will be processed offline using dedicated algorithms to separate ventilation and perfusion signals and to extract pulsatility-related parameters (e.g., amplitude, area, inflection points). These values will then be compared with RHC-derived hemodynamic measures such as mean pulmonary artery pressure (mPAP), pulmonary vascular resistance (PVR), cardiac output (CO), and stroke volume (SV).

The primary outcome of this study is to determine the diagnostic accuracy of EIT for detecting pulmonary hypertension, aiming at high sensitivity and clinical utility as a screening tool prior to invasive catheterization. Secondary analyses will include exploration of additional EIT-derived perfusion and pulsatility indices, assessment of diagnostic thresholds for different levels of PAH severity, and evaluation of prognostic implications.

Risks associated with participation are minimal, as EIT is non-invasive and safe. The risks of RHC are those inherent to the procedure and are independent of the study. While no direct benefit is expected for individual participants, the findings may provide important insights into the use of EIT as a less invasive diagnostic strategy for PAH, with potential implications for clinical practice and patient care.

Study Type

Interventional

Enrollment (Estimated)

120

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Brazil
    • São Paulo
      • São Paulo, São Paulo, Brazil, 05403-900
        • Recruiting
        • Instituto do Coração do Hospital das Clínicas da Faculdade de Medicina da USP
        • Contact:
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Patients with a diagnosis or clinical suspicion of pulmonary arterial hypertension (PAH) and with a medical indication for right heart catheterization.
  • Patients evaluated at the Pulmonology Service of InCor-HCFMUSP.

Exclusion Criteria:

  • Pregnancy.
  • Structural heart disease, such as atrial septal defect, ventricular septal defect, or valvular disease.
  • Cardiac arrhythmias.
  • Presence of a cardiac pacemaker or other implantable electronic device.
  • Skin lesions at the thoracic region that would prevent placement of the EIT electrode belt.
  • WHO functional class IV of new york heart association (NYAH)..
  • Inability to perform a voluntary respiratory pause (apnea) of at least 30 seconds or inability to understand and follow instructions required.
  • Decline to participate in the study by not signing the informed consent form or refusal by the attending medical team.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Diagnostic Arm
Patients with suspected or confirmed pulmonary arterial hypertension (PAH) undergoing right heart catheterization will also be monitored with electrical impedance tomography (EIT) around the time of the procedure. EIT-derived signals will be compared with invasive hemodynamic measurements.
Diagnostic test: Electrical Impedance Tomography (EIT)
Non-invasive, radiation-free bedside monitoring of ventilation and pulmonary perfusion. Patients will be monitored for a short period using EIT, with data analyzed offline to assess pulsatility and perfusion indices.
Procedure: Right Heart Catheterization
Standard invasive hemodynamic assessment performed for clinical indication, including measurement of pulmonary artery pressure, cardiac output, pulmonary vascular resistance, and stroke volume. Used as the gold standard comparator for EIT-derived measures.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Sensitivity (%) of Electrical Impedance Tomography (EIT)-Derived Pulsatility Amplitude for Detection of Pulmonary Hypertension Defined by Mean Pulmonary Artery Pressure
Time Frame: At the time of right heart catheterization (baseline, single assessment)
Sensitivity (%) of EIT-derived pulsatility amplitude (measured in arbitrary impedance units, ΔZ) to detect pulmonary hypertension defined as mean pulmonary artery pressure (mPAP ≥20 mmHg) measured in mmHg by Right Heart Catheterization (RHC). Diagnostic performance will be assessed using Receiver Operating Characteristic (ROC) curve analysis and area under the curve (AUC).
At the time of right heart catheterization (baseline, single assessment)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pearson or Spearman Correlation Coefficient (r) Between EIT-Derived Pulsatility Amplitude (ΔZ) and Mean Pulmonary Artery Pressure (mmHg)
Time Frame: At the time of right heart catheterization
Correlation coefficient (r) between EIT-derived pulsatility amplitude (ΔZ, arbitrary impedance units) and mean pulmonary artery pressure (mmHg), pulmonary vascular resistance (Wood units), cardiac output (L/min), and stroke volume (mL), all measured invasively by Right Heart Catheterization.
At the time of right heart catheterization
Correlation Coefficient (r) Between EIT Pulsatility Amplitude and Fractional Area Change (%)
Time Frame: Immediately after right heart catheterization (single assessment at baseline)
Correlation between EIT-derived pulsatility amplitude (ΔZ) and Fractional Area Change (%, measured in millimeters by transthoracic echocardiography).
Immediately after right heart catheterization (single assessment at baseline)
Correlation Coefficient (r) Between EIT Pulsatility Amplitude (ΔZ) and Tricuspid Annular Plane Systolic Excursion (mm)
Time Frame: Immediately after right heart catheterization (single assessment at baseline)
Correlation between EIT-derived pulsatility amplitude (ΔZ) and Tricuspid Annular Plane Systolic Excursion (TAPSE, measured in millimeters by transthoracic echocardiography).
Immediately after right heart catheterization (single assessment at baseline)
Correlation Coefficient (r) Between EIT Pulsatility Amplitude and Tissue Doppler Systolic Velocity (cm/s)
Time Frame: immediately after right heart catheterization
Correlation between EIT-derived pulsatility amplitude (ΔZ) and Tissue Doppler Systolic Velocity (cm/s). (S', measured in millimeters by transthoracic echocardiography).
immediately after right heart catheterization
Sensitivity (%), Specificity (%), and Area Under the ROC Curve (AUC) of EIT Pulsatility Amplitude for Detection of Pulmonary Hypertension at Different mPAP Thresholds
Time Frame: At the time of Right Heart Catheterization.
Diagnostic performance of EIT-derived pulsatility amplitude (ΔZ) to detect pulmonary hypertension defined by mean pulmonary artery pressure thresholds of ≥20 mmHg and ≥40 mmHg measured by Right Heart Catheterization.
At the time of Right Heart Catheterization.
Area Under the ROC Curve (AUC) of EIT Pulsatility Amplitude for Classification of Pulmonary Hypertension Severity
Time Frame: At the time of right heart catheterization
Ability of EIT-derived pulsatility amplitude (ΔZ) to classify pulmonary hypertension severity categories defined by mean pulmonary artery pressure ranges (20-40 mmHg vs >40 mmHg), measured invasively by Right Heart Catheterization.
At the time of right heart catheterization

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Sao Paulo General Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 26, 2024

Primary Completion (Estimated)

December 1, 2026

Study Completion (Estimated)

December 1, 2026

Study Registration Dates

First Submitted

September 29, 2025

First Submitted That Met QC Criteria

February 27, 2026

First Posted (Actual)

March 5, 2026

Study Record Updates

Last Update Posted (Actual)

March 5, 2026

Last Update Submitted That Met QC Criteria

February 27, 2026

Last Verified

September 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 76762824.6.0000.0068

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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